FDA Takes Civil Penalty Lawsuits Against 25 US Retailers for Illegally Selling Unapproved Vapes

Regulations by 2FIRSTS.ai
Dec.06.2023
FDA Takes Civil Penalty Lawsuits Against 25 US Retailers for Illegally Selling Unapproved Vapes
FDA fines 25 US retailers and online shops for illegally selling unapproved e-cigarette products, targeting youth-favored brand ELFBAR.

According to an announcement made by the US Food and Drug Administration (FDA) on December 5th, the FDA has filed civil monetary penalty (CMP) lawsuits against 25 physical stores and online retailers in the United States. These retailers have been illegally selling e-cigarette products that have not yet obtained FDA approval.

 

The FDA had previously issued warning letters to each retailer, urging them to cease the sale of unauthorized tobacco products. However, subsequent inspections revealed that these retailers failed to rectify their non-compliant behavior, resulting in the imposition of these civil fines by the FDA.

 

According to the 2023 National Youth Tobacco Survey data, e-cigarette products are especially popular among young people. The survey revealed that ELFBAR is the most frequently used brand of e-cigarettes among middle and high school students, with a usage rate as high as 56.7%.

 

Lawsuits demand that a maximum fine of $19,192 be imposed on each retailer for a single violation. Retailers have the option to either pay the fine, reach a settlement agreement based on mitigating factors, request an extension to respond to the lawsuit, or submit a reply and request a court hearing. Failure to take any action within 30 days of receiving the lawsuit may result in a default judgment requiring the retailer to bear the full amount of the fine.

 

As of today, a total of 67 lawsuits have been filed against retailers for selling unauthorized e-cigarettes. In September and November, the FDA initiated similar monetary requests for civil money penalties (CMP) against 42 physical retail establishments in 18 states for selling unauthorized products.

 

This operation encompasses retailers from 14 states, marking the first time cases have been brought against online retailers.

 

We welcome news tips, article submissions, interview requests, or comments on this piece.

Please contact us at info@2firsts.com, or reach out to Alan Zhao, CEO of 2Firsts, on LinkedIn


Notice

1.  This article is intended solely for professional research purposes related to industry, technology, and policy. Any references to brands or products are made purely for objective description and do not constitute any form of endorsement, recommendation, or promotion by 2Firsts.

2.  The use of nicotine-containing products — including, but not limited to, cigarettes, e-cigarettes, nicotine pouchand heated tobacco products — carries significant health risks. Users are responsible for complying with all applicable laws and regulations in their respective jurisdictions.

3.  This article is not intended to serve as the basis for any investment decisions or financial advice. 2Firsts assumes no direct or indirect liability for any inaccuracies or errors in the content.

4.  Access to this article is strictly prohibited for individuals below the legal age in their jurisdiction.

 

Copyright

 

This article is either an original work created by 2Firsts or a reproduction from third-party sources with proper attribution. All copyrights and usage rights belong to 2Firsts or the original content provider. Unauthorized reproduction, distribution, or any other form of unauthorized use by any individual or organization is strictly prohibited. Violators will be held legally accountable.

For copyright-related inquiries, please contact: info@2firsts.com

 

AI Assistance Disclaimer

 

This article may have been enhanced using AI tools to improve translation and editorial efficiency. However, due to technical limitations, inaccuracies may occur. Readers are encouraged to refer to the cited sources for the most accurate information.

We welcome any corrections or feedback. Please contact us at: info@2firsts.com

Nicotine Pouches Lead U.S. Tobacco Growth as Vape Sales Decline
Nicotine Pouches Lead U.S. Tobacco Growth as Vape Sales Decline
New convenience store industry data show nicotine pouches have become the primary growth driver in the tobacco category, with oral nicotine sales rising nearly 30% over the past year while vape sales declined.
Business
Jun.05
U.S. Convenience Stores Rebalance Backbar as Nicotine Pouches Outpace Cigarettes
U.S. Convenience Stores Rebalance Backbar as Nicotine Pouches Outpace Cigarettes
As cigarette volumes continue to decline, U.S. convenience-store operators are reconfiguring backbar space to accommodate modern oral nicotine products such as nicotine pouches. Industry data show nicotine pouches have become one of the fastest-growing nicotine categories while generating higher margins for retailers.
Jun.12
PMI’s ZYN Launches Loyalty Platform in Mexico, Tapping World Cup Viewing Scenes for Nicotine Pouch Marketing
PMI’s ZYN Launches Loyalty Platform in Mexico, Tapping World Cup Viewing Scenes for Nicotine Pouch Marketing
PMI’s nicotine pouch brand ZYN has launched the ZYN Club loyalty platform in Mexico and introduced ZYN Live Stadium viewing experiences around football matches, showing how nicotine pouch brands are using rewards, limited benefits and offline consumption settings to reach adult consumers.
Jun.29
South Korea Moves Against Synthetic Nicotine Regulatory Gap as Three Companies Face Tobacco Business Act Probe
South Korea Moves Against Synthetic Nicotine Regulatory Gap as Three Companies Face Tobacco Business Act Probe
South Korea’s Ministry of Finance and Economy said on May 4 that it requested the Daejeon Metropolitan Police Agency and Gyeonggi Nambu Provincial Police Agency to investigate three sales companies on suspicion of violating the Tobacco Business Act.
May.06 by 2FIRSTS.ai
Oral Thin-Film Technology Firm CTT Pharma Eyes U.S. Nicotine Product Trials
Oral Thin-Film Technology Firm CTT Pharma Eyes U.S. Nicotine Product Trials
CTT Pharmaceutical Holdings said it has signed a letter of intent with a U.S. company to conduct clinical trials and testing for several potential nicotine products using its patented oral thin-film technology.
Jun.18
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Reports Fiscal Q3 2026 Revenue of $18.7 Million and Net Loss of $9.5 Million
Ispire Technology reported financial results on May 7, 2026, for the third quarter of fiscal 2026, covering the three months ended March 31, 2026. Revenue was $18.7 million, compared with $26.2 million in the third quarter of fiscal 2025 and $20.3 million in the prior quarter. Gross profit was $2.0 million, with gross margin of 10.7%. Net loss was $9.5 million, or $0.17 per share. The company said it held $18.0 million in cash as of March 31, 2026, up $468,000 sequentially.
May.08 by 2FIRSTS.ai